Eudralex Volume 3 ICH M7(R2) Questions and Answers on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

Title:
Eudralex Volume 3 ICH M7(R2) Questions and Answers on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
Short Title:
EMA/CHMP/SWP/431994/2007 Rev. 3

https://www.gmp-compliance.org/files/guidemgr/ich-m7r2-questions-and-answers-assessment-and-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit-potential-carcinogenic-risk-step-5_en.pdf

Origin/Publisher:

EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK

Document Type:
Guideline
Content:
This document provides clarification on questions concerning the 'Guideline on the limits of genotoxic impurities'

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